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FDA 510(k)

iTero Element 5D

K-Number: K193659 · 2020-03-20

ApplicantAlign Technology, Inc.
Decision Date2020-03-20
Product CodeNTK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

iTero Element 5D is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology, Inc.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K193659. The device is classified under product code NTK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iTero Element 5D?

iTero Element 5D is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Align Technology, Inc.. The 510(k) number is K193659.

When did iTero Element 5D receive FDA 510(k) clearance?

iTero Element 5D received FDA 510(k) clearance on 2020-03-20, under 510(k) number K193659.

Who is the listed applicant for iTero Element 5D?

The FDA 510(k) record lists Align Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iTero Element 5D?

The FDA product code for iTero Element 5D is NTK.

Other records listing Align Technology, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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